MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE

Catalog Number 89-8507-400-10

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(4), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The motor was seized.Additionally, there was a leakage issue at the battery support.The motor, screws, and seals were replaced and resolved the reported issue.The potted wired controller, battery support, and seals were updated.Dhr review was performed.Device was 70 months old and is not out of box failure.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12065771
• MDR Text Key: 258326392
• Report Number: 0008031000-2021-00022
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00889024354609
• UDI-Public: (01)00889024354609(11)150302(10)5006009
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-10
• Device Lot Number: 5006009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization